safety, tolerability, and immunogenicity study of investigational recombinant botulinum vaccine a/b (rbv a/b) in volunteers previously immunized with investigational pentavalent botulinum toxoid

Conditions: Botulism

Summary: study rbv a/b-cl-001 is a phase 2b, 2-part, open-label, uncontrolled study to evaluate safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine a/b (rbv a/b) for the production of babybig in volunteers previously immunized with the pentavalent botulinum (pbt) toxoid. this study is designed to determine neutralizing antibody levels for botulinum toxin types a and b in healthy subjects who were previously immunized with the pbt for occupational protection and who receive the rbv a/b. subjects with titers of the neutralizing antibodies against the toxins would be candidates for plasma donation for babybig production.


Eligibility criteria:
inclusion criteria: * the volunteer has received pentavalent botulinum toxoid for occupational protection under bb ind 0161, with the previous pentavalent botulinum toxoid dose at least 6 months prior to the planned rbv a/b dose. * the volunteer is between the ages of 18 and 69 years at the time of consent. * the volunteer is healthy and has an acceptable medical history. * the volunteer meets the subject suitability requirements and recommendations for source plasma donors (for part 2 subjects only). * the volunteer, if female and of childbearing potential, is not pregnant or lactating, and agrees to use an acceptable form of fda-approved contraception for the duration of the study. * the volunteer has the ability to understand the requirements of the study and provide informed consent. * the volunteer agrees to complete the subject diary on a daily basis for 7 days post-vaccination and to report concomitant medication and adverse events during the study period. * the volunteer provides written authorization for use and disclosure of protected health information. * the volunteer agrees not to donate blood or blood products (outside of study procedures) during the course of the study. * the volunteer has personal health insurance. exclusion criteria: * be pregnant or nursing * the volunteer has a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome, creutzfeldt-jakob disease, or infection with human immunodeficiency viruses 1 or 2, human t cell lymphotropic virus 1, hepatitis b virus, or hepatitis c virus. * the volunteer had prior severe local or severe systemic reaction to last immunization with pentavalent botulinum toxoid. * the volunteer has a known allergy to aluminum compounds, yeast, or other components of the vaccine. * the volunteer has donated one or more units of blood or undergone plasmapheresis within 28 days before screening. * the volunteer has received a blood product or immunoglobulin within 6 months of screening or plans to receive such products during the study. * the volunteer has received licensed nonliving vaccine within 14 days before study entry or licensed live vaccine within 60 days before study entry. * the volunteer has received investigational products (drugs, biologics, vaccines, or implantable devices) 60 days prior to study entry or plans to receive experimental products at any time during the study. * the volunteer has received prescription immunosuppressive or immunomodulatory agents, including parenteral, inhaled, or oral corticosteroids within 3 months before screening or plans on receiving such therapy at any time during the study with the exceptions (subjects who have used prescription topical steroids may be enrolled 2 weeks after the therapy is completed; intra-articular, bursal, or tendon injectable steroids are permitted; any over-the-counter topical steroid use is permitted; ophthalmic and intranasal steroids are permitted). * the volunteer has received cytotoxic therapy at any time in the previous 5 years to study entry. * the volunteer has an active systemic or recurrent disease that would place the subject at unacceptable risk of injury, require hospitalization, or require surgical intervention. * the volunteer has a history of alcohol or drug abuse within 12 months before screening. * the volunteer has past, present, or suspected illicit injection drug use. * the volunteer has inflammatory, vasculitic, or rheumatic disease, including systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma. * the volunteer has clinically recognized hepatic or renal insufficiency. * the volunteer has uncontrolled hypertension. * the volunteer has moderate to severe asthma, chronic obstructive pulmonary disease, or other significant pulmonary disease. * the volunteer has a seizure disorder. * the volunteer has moderate or severe illness or oral temperature of 100.4°f or greater within 3 days prior to immunization. * the volunteer is determined by the investigator to be unsuitable for participation in this trial for any reason.

Keywords: botulism vaccine